Senior Clinical Research Associate
Allucent, Hungary
Job Description
Allucent is a full-service contract research and development organization with international resources dedicated to helping pharmaceutical and biotechnology companies efficiently and expeditiously navigate the regulatory approval process in order to bring new drugs, biologics, and medical devices to the people who need them. Allucent is a non-laboratory environment. At Allucent, our mission is to help bring new therapies to light. When you work at Allucent, that means rolling up your sleeves and applying your scientific knowledge, clinical expertise, and experience to partnerships with our clients in small and mid-sized biotech companies.
These customers have new therapeutic ideas but want a partner who can assist with the clinical trial process, the complexities of certain disease states, or other critical capacities. You’ll work with them on the newest treatment breakthroughs for some of the most perplexing conditions. And ultimately, you’ll help make a positive difference in patients’ lives.
Responsibilities:
- Perform initiation visits to train and instruct site staff on the study specific requirements
- Assist in site activation
- Perform Monitoring visits to:
- Verify that source data and study database are accurate, complete and maintained properly
- Verify subject eligibility
- Verify protocol compliance, including safety reporting and drug handling
- Verify all study files are maintained and up to date
- Support site staff in preparation for study specific site audits and inspections
- Perform Close-out visits
- Perform Pre-study visits, if delegated by SSU
- Perform centralized and risk based monitoring activities
- Act as the main line of communication between the study PM/LCRA and the site staff
- Maintain study related trackers
- Prepare site visit reports
- Liaise with site staff to achieve patient recruitment targets
- Contribute to the development of study specific documents
- Support the study start-up team in preparation of the submission packages and collection of site documents, if delegated by SSU
- Actively support site management staff learning amp; development within the company
Requirements
Qualifications
- Life science, healthcare, medicine and/or related degree
- Minimum 3 year of CRA experience
- Minimum 3 years of experience in drug development and/or clinical research
- Thorough knowledge of ICH-GCP, privacy legislation (GDPR and/or HIPPA), regulations (CTR/CTD and/or CFR), and applicable local regulatory requirements
- Good understanding of site management and monitoring
- The ability to perform site visits in an effective way and having performed all different types of site visits (Initiation visit, Monitoring visit and Close-out visits)
Skills:
- Strong written and verbal communication skills including good command of French and English language
- Representative, outgoing and client focused
- Ability to work in a fast-paced challenging environment of a growing company
- Administrative excellence with attention to detail and accuracy
- Proficiency with various computer applications such as Word, Excel, and PowerPoint required
- Strong organizational skills
Benefits
- Comprehensive benefits package
- Competitive salaries per location
- Departmental Study/Training Budget for furthering professional development
- Flexible Working hours (within reason)
- Opportunity for fully remote working or Hybrid Working Model
- Leadership and mentoring opportunities
- Internal growth opportunities and career progression
- Up to 8 days monitoring on site (includes remote visits)
- Financially rewarding internal employee referral program
- Access to online soft-skills and technical training via GoodHabitz and internal platforms
To all recruitment agencies: Allucent does not accept agency resumes. Please do not forward resumes to our careers alias or other Allucent employees. Allucent is not responsible for any fees related to unsolicited resumes.#LI-AH1